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Switching From Tobramycin Inhalation Treatment to Tobramycin Inhaler Treatment: The Effect on CF Patients' Adherence and Quality of Life

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01749644
First Posted: December 17, 2012
Last Update Posted: December 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheba Medical Center
  Purpose
Pseudomonas is a common and virulent respiratory bacteria in patients with Cystic Fibrosis (CF). With time, the infection with Pseudomonas becomes chronic and very difficult to eradicate. The standard treatment of chronic Pseudomonas infection is inhaled Tobramycin which is given every other month.. Inhalation of Tobramycin was proven as an effective treatment that improves the respiratory function and reduces the concentration of bacteria in the sputum. However, inhaled treatment lasts between 15 to 30 minutes twice a day and therefore adherence is a major problem. The effect of switching from inhalation treatment to inhaler treatment on patient's adherence and quality of life has not been studied.

Condition
Alteration in Quality of Life of CF Patients, Following Change of Treatment From Antibiotic Inhalation to Antibiotic Inhaler

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Improvement in quality of life [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Difference in exacerbation events [ Time Frame: 1 year ]

    To be measured by:

    Worsening of CF symptoms such as coughing, sputum, deterioration in FEV1, all of which require hospitalization



Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
CF patients with chronic pseudomonas infection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CF patients with chronic pseudomonas infection
Criteria

Inclusion Criteria:

  • Age 6 years and above, Chronic Pseudomonas infection

Exclusion Criteria:

  • Younger than 6 years; No chronic PSeudomonas infection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749644


Contacts
Contact: Ori Sarouk, MD 97235302884 ifat.sarouk@sheba.health.gov.il

Locations
Israel
Safra Children's Hospital, Sheba Medical Center Not yet recruiting
Ramat Gan, Israel
Contact: Ifat Sarouk, MD    97235302884      
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ori Efrati, MD Safra Children's hospital, National CF Center
Principal Investigator: Ifat Sarouk, MD Safra Children's Hospital, National CF center
  More Information

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01749644     History of Changes
Other Study ID Numbers: SHEBA-12-9640-OE-CTIL
First Submitted: December 12, 2012
First Posted: December 17, 2012
Last Update Posted: December 18, 2012
Last Verified: December 2012

Keywords provided by Sheba Medical Center:
Cystic Fibrosis, Chronic Pseudomonas Infection, Inhaled Tobramycin

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents